Masterarbeit

Comparison of vigilance legislation – Procedures for medical devices and medicinal products ***

Dr. Anja Limberg (2020)

Summary
Language: English
Medical devices and medicinal products are governed by two distinct legal systems. The new MDR of April 2017 has brought about substantial changes regarding proactive and continuous oversight duties of the manufacturer after placing a device on the market, referred to as post-market surveillance, and the reinforcement of vigilance and market surveillance requirements. Key elements of the drug pharmacovigilance legislation that underwent major revision in 2010/2012 can be recognized in the new post-market provisions for devices. However, important differences between the two sectors remain. They can in part be explained by their different histories and the distinct nature of products.
For healthcare products on the border between medical devices and medicinal products the exact definition of the intended medical purpose is decisive for their classification. The applicable regulatory status doesn’t only affect the type of assessment procedure and data requirements for placing on the market but also determines under which vigilance legislation the respective product falls.
Main focus of this thesis is a comparison of similarities and differences in the vigilance provisions for medical devices and medicinal products with regard to periodic re-evaluation of the benefit-risk profile, life cycle approach for monitoring of product safety, reporting of incidents/adverse reactions, data analyses obligations on authorities and manufacturers/ marketing authorization holders for detection of signals and trends pointing to new risks, and established procedures for the assessment of safety concerns. The thesis highlights strengths and weaknesses of the two systems and outlines considerations for borderline products.
Pages: 90